Evaluating The Role Of Montelukast In Management Of Acute Bronchiolitis
ConditionAcute Bronchiolitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age4-2
SponsorPakistan Institute of Medical Sciences
About this trial
This study aims to evaluate the role of Montelukast in management of acute Bronchiolitis in indoor patient and how this drug shortens the duration of admission and improves symptoms
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 4 weeks to 2 years
Both genders
Duration of respiratory symptoms less than 4 days
Clinical diagnosis of acute bronchiolitis according to the operational definition provided in the study protocol
Disqualifiers
History of asthma
Previous hospital admissions for respiratory illness
Use of asthma medications
Congenital heart disease
Trial design
Design model
Parallel
Treatments tested in this trial
Montelukast
DrugAdministrating montelukast to experimental group and monitoring response
Placebo
DrugPlacebo sugar granules administered orally once daily at night according to the same schedule as montelukast 4 mg sachet, in addition to standard supportive care for acute bronchiolitis
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: MontelukastExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Clinical Severity Score from Baseline to 72 Hours
Change in the study-defined Clinical Severity Score from baseline at hospital admission to 72 hours after initiation of treatment. The score ranges from 0 to 12 and is calculated from heart rate, wheezing, respiratory rate, dyspnea, respiratory support, and feeding difficulties, with each component scored from 0 to 2. Higher scores indicate greater clinical severity. The change in score will be compared between the montelukast and placebo groups
Time frame
Baseline (hospital admission) and 72 hours after initiation of treatmentSecondary outcomes
1
Length of Hospital Stay
Length of hospital stay measured in hours from hospital admission until hospital discharge. Discharge is defined by resolution of symptoms, including improved feeding, absence of respiratory distress, a clinical severity score less than 3, and respiratory rate within the normal range for age.
Time frame
From baseline (hospital admission;day 1) through hospital discharge ( day 7)Sponsors and contacts
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Source ClinicalTrials.gov